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510(k) Data Aggregation

    K Number
    K031319
    Device Name
    OSTEO-G BONE VOID FILLER SYSTEM
    Manufacturer
    ASPINE USA, INC.
    Date Cleared
    2003-07-17

    (83 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASPINE USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osteo-G Bone Void Filler System, pellets or paste, are intended for filling of bony voids or gaps, i. e., of the extremities, spine or pelvis, that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets or paste provide a bone void filler that is bioabsorbable and is replaced with bone during the healing process. Osteo-G Bone Void Filler System pellets or paste may be used at an infected site.
    Device Description
    The Osteo-G Bone Void Filler System is an osteoconductive, bioabsorbable, calcium sulfate dihydrate implant for use as a bone graft substitute or bone void filler. The system consists of prefabricated calcium sulfate dihydrate pellets or a kit for fabricating calcium suffate dihydrate implants to custom shape and size or for in situ use. The device is radiopaque and is presterilized for single use. The Osteo-G Bone Void Filler System pellets are provided in three sizes, each with cylindrical shape, as follows: - a) 5 mm diameter, 5 mm high - b) 5 mm diameter, 3 mm high - c) 3 mm diameter, 3 mm high The Osteo-G Bone Void Filler System kit is provided in one size: a ten gram quantity of calcium sulfate hemihydrate powder component with a three milliliter mixing solution component. Once mixed, the powder and solution produce a moldable paste that can be custom shaped.
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